In a glitzy roll-out last February that featured both First Lady Michelle Obama and the U.S. Food and Drug Administration (FDA) Commissioner Margaret Hamburg, M.D., the FDA proudly announced its first major changes to nutrition and supplement labeling in more than 20 years. In effect, the Agency proposed “to update the Nutrition Facts label for packaged foods to reflect the latest scientific information, including the link between diet and chronic diseases such as obesity and heart disease. The proposed label also would replace out-of-date serving sizes to better align with how much people really eat, and it would feature a fresh design to highlight key parts of the label such as calories and serving sizes” (1).

But what will this mean to us in real life? How will the proposed label changes affect our businesses, our products, even our health? Obama’s and Hamburg’s words are nice and soothing, but ultimately uninformative. One thing is certain, though: the FDA planners are living in the past. They are still fighting past battles that more recent nutritional knowledge reveals as nothing but a sideshow. However, as you read on, you will discover the real hidden agenda that the FDA has—one that is both dangerous and threatening to your very health. Perhaps the FDA planners are more clever and devious than anyone gave them credit for being.

The New Label Emphasizes Calories and Serving Size
Starting with the mundane changes proposed by the FDA, you will see a large number of formatting and placement changes from the existing Nutrition Facts panel—including the placement of calories—in the 109 pages of the FDA’s Proposed Rulemaking (2). Because the FDA is still stuck in the old paradigm of nutritional mythology that says that counting calories will control obesity rates, it has decided to shove the calorie number in consumers’ faces with a much larger typeface that is also boldfaced so that no one could possibly miss seeing it. Strobe lighting, I understand, is optional.

So, too, with pushing the “Serving Size” number front and center so that consumers will have to read it first. The concept here is that consumers actually pay attention to the statement of serving size when deciding how much of a particular food to eat. I have yet to meet one of these mythical creatures. Aside from those of you who must look at serving size for your work, or who are OCD calorie counters, who among you can honestly say that you ever gave any consideration whatsoever to serving size when deciding how much food in a package to eat? You eat until you are full, or until the package is empty.

Moreover, despite FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor’s bubbly claim that these changes will “help address obesity” by driving attention to calories and serving size, they will actually distract consumers from the real nutritional issues: such as the nutritional “density” of the food (i.e., whether or not it is rich in vitamins, minerals and other nutrients) and whether artificial sweeteners and other true fatteners are present. Now, consumers can continue drinking their super-sized diet colas, secure in their FDA-supported fantasy that losing weight is all about quantity (calories) and not quality.

The New Label Has Larger Serving Sizes
Another proposed change would, as the FDA states, “Update serving size requirements to reflect the amounts people currently eat.” As the FDA argues, “What and how much people eat and drink has changed since the serving sizes were first put in place in 1994. By law, serving sizes must be based on what people actually eat, not on what people ‘should’ be eating.”

In this respect, the FDA talks good sense about wanting to “present calorie and nutrition information for the whole package of certain food products that could be consumed in one sitting.” A single serving of ice cream, for example, would no longer be a half cup but rather a full cup.

The problem —once again—is that most people do not pay attention to serving sizes when they eat. They pay attention to their appetite. A “serving size” is whatever it takes to fill them up. Yes, it does make sense to increase the serving sizes in light of “modern” eating habits, but will that achieve the FDA’s stated goals of reducing obesity and heart disease? Very unlikely. But at least this change is a step in the right direction of recognizing that Americans are eating significantly larger food portions.

The New Label Mentions “Added Sugars”
The current label requirement is for a mandatory declaration of sugar only. But, as the FDA announced in its press release, “The 2010 Dietary Guidelines for Americans states that intake of added sugar is too high in the U.S. population and should be reduced. The FDA proposes to include ‘added sugars’ on the label to help consumers know how much sugar has been added to the product.”

Americans currently eat 60% more sugar than the World Health Organization (WHO) recommends and the FDA intends to address that problem with an added mandatory declaration of “Added Sugars.” This tracks, by the way, with the discussion at Codex Alimentarius meetings about declaring “added sugars” on the food labels of its member States.

Still, as admirable as this effort is, once again, it will have the public looking in the wrong direction—looking for “added sugars” instead of also looking for zero-calorie artificial sweeteners that are brain-damaging and far less healthy. Dangerous additives like aspartame and sucralose will not be disclosed in this revised Nutrition Panel and consumers will be misled into thinking that their selection of a zero “Added Sugars” product is healthier.

The New Label Deletes “Calories from Fats”
Recognizing that the type of fat rather than the amount is the key, the FDA has correctly proposed to delete “Calories from Fats” from the Nutrition Facts panel. Given the FDA’s fixation on spotlighting total calories, this deletion is a curious, but promising change for the Agency to make. On the other hand, the FDA still thinks that polyunsaturated fats are God’s gift to Mankind, so we have another swing and a miss.

Fluoride to be Declared
Although an increasing number of people are realizing that fluoride can be a public health hazard, especially when added as mass medication to our water supplies, others still think that fluoride is, as the FDA states, a nonessential nutrient “but one with well-established benefits for the teeth.” Never mind that fluoride displaces beneficial selenium in the body, and certainly never mind that the fluoride–cavity connection is tenuous at best. With this outdated view of fluoride in mind, the FDA is proposing that fluoride content may now be disclosed—voluntarily—on food labels.

Of course, for those of us who would prefer to avoid fluoride, this label change is not unwelcome at all. It is just ironic that many of us will use the fluoride label declaration as a means of avoiding its intake rather than ensuring it as the FDA has envisioned.

Deemphasizing Some Nutrients
The FDA will require the declaration of potassium and vitamin D in place of vitamins A and C, since the Agency has decided that the former are currently more important than the latter for public health. As the FDA states, “some in the U.S. population are not getting enough of [potassium and vitamin D], which puts them at higher risk for chronic disease. Vitamin D is important for its role in bone health. Potassium is beneficial in lowering blood pressure.”

Although dethroned and no longer required on labels if the proposed changes become final, vitamins A and C could still be voluntarily declared by manufacturers. The FDA has its flavors of the decade and these two are no longer them.

Say Goodbye to International Units
Not content enough with all of these label changes (as well as many more too numerous to discuss in this column), the FDA has decided to strike back at me personally by taking away my beloved International Units. Yes, in some sort of Euro-trash move, the FDA is abandoning the International-Unit potency designations for Vitamins A, D, and E, and replacing them with mcg RAE for Vitamin A, μg for Vitamin D, and mg α-tocopherol for Vitamin E. Section 101.9(c)(8)(iv) of the Food, Drug, and Cosmetic Act will be amended; and those of you who, like me, were so accustomed to thinking of these vitamins potencies in International-Unit potencies will now have to acclimate to the European metric potencies.

To be fair, the change does make for more consistency with the metric potencies for all other vitamins and minerals on the label. In addition, but perhaps ominously, this change will also harmonize U.S. measures to European and Codex measures, which makes comparisons easier but which also, as you will see below, dovetails very dangerously with plans to harmonize American vitamin-and-mineral potencies to those of less-enlightened jurisdictions.

A Distraction?
What is the current hot-button label issue in America today? If you answered anything other than GMO labels, then you have indeed been living under a rock. People are in rebellion over GM crops and the dangers that they pose. GMO label initiatives are almost as prolific in America as NSA wiretaps are on our phones. What better way to divert the GMO-label issue than to raise another label issue? Did anyone wonder why the FDA has suddenly decided, after 20 years, to propose these changes?

If the FDA were truly concerned about consumer awareness and information through labels and labeling, then the Agency would have also proposed GMO label disclosure (and prominent disclosure of aspartame and other sweeteners). But, we all know that the FDA’s main focus is not consumer health, nor has it been for a very, very long time.

Even Worse, a Blow to Nutrient Levels
While everyone is focused on the flurry of format changes, replacement of verbiage and the fancy new look, there—hidden in plain view like the Purloined Letter—is the real danger to our health. The FDA is harmonizing our vitamin-and-mineral levels to those of Codex Alimentarius. Not 100%, but mostly. Those dirty sneaks.

Ever since the National Health Federation’s victory at the 2009 Codex Committee on Nutrition and Foods for Special Dietary Uses meeting (where an Australian-led attempt to reduce, across the board, vitamin-and-mineral Nutrient Reference Values [NRVs] was rebuffed), Australia and other Codex delegations have continued pushing their anti-nutrient agenda. Conspicuously silent during these debates has been the U.S. delegation. Now we know why.

Interestingly enough, Codex Alimentarius is mentioned in the FDA’s Proposed Rulemaking multiple times. And with this Proposed Rulemaking, the FDA wants to dumb down our Daily Values to the abysmally low Codex levels with no fewer than eight vitamins and minerals, while one (folic acid) already matches the Codex NRV and two others are within spitting distance. In the case of biotin, FDA proposes to cut its Daily Value by 90% in order to match the Codex value (3)!

Going back to at least its October 11, 1995, pronouncement in the Federal Register, the FDA has made no secret of its intention and desire to harmonize its food laws with those of the rest of the world. This Proposed Rulemaking and label changes simply prove that this intention is still very much alive. Were those global standards for vitamins and minerals higher than our own, then such a change might be advisable, even admirable. But we all know that most of the rest of the world despises supplementation, either separately or in foods, and since these proposed label changes for daily values apply equally to the Supplement Facts panel as they do to the Nutrition Facts panel, they are very dangerous changes indeed.

There is a connection between these proposed daily values and maximum upper permitted levels, with harmonized global standards paving the way for reduced vitamin-and-mineral levels whether in pill form or food form. This is my 15th year of actively following and arguing about dietary-supplement and general-food standards and guidelines at Codex meetings and I have seen the trend. Believe me, the trend is not your friend, not here.

These Are Proposed Changes
You will not see these changes right away. First of all, they are proposed, not final. The FDA is accepting comments from the public for a 90-day period, which ends on June 2, 2014. Comments regarding the FDA’s proposed label changes may be submitted electronically to the agency at http://www.regulations.gov or in writing to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5360 Fishers Lane, Rm. 1061, Rockville, MD 20852. Mention Docket No. FDA-2012-N-1210.

Secondly, once the Proposed Rulemaking becomes final, food manufacturers will have two years to bring their labels into compliance with the final rule. The FDA estimates that it will cost the industry approximately $2 billion to comply, but government is rarely correct about the true and final costs of compliance.

The FDA has dressed up its anti-nutrient label changes with all manner of accessories. But don’t be fooled by the bling, for at the core lay the FDA’s ignorance about and antipathy towards the benefits of vitamins and minerals. Tell the FDA exactly how wrong it is. WF

A graduate of the University of California at Berkeley Law School, Scott C. Tips currently practices internationally, emphasizing Food-and-Drug law, business law and business litigation, trade practice, and international corporate formation and management. He has been involved in the nutrition field for more than three decades and may be reached at (415) 244-1813 or by e-mail at scott@rivieramail.com.

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